Standing Committee A

[Mr. James Cran in the Chair]

Mental Capacity Bill

Clause 28 - Mental Health Act matters

Question proposed, That the clause stand part of the Bill.

James Cran: With this it will be convenient to consider the following:New clause 6 Duties of the responsible clinician

New clause 6 - Duties of the responsible clinician

'(1) The responsible clinician may be any registered doctor responsible for P's assessment and medical treatment at the relevant time. 
 (2) If P's responsible clinician considers that the conditions specified in section E (2) to (7) are met in relation to a medical treatment to which section D applies, he must notify— 
 (a) the Secretary of State, and 
 (b) any other person of a description specified in regulations made by the Secretary of State.'.

New clause 7 - Cases where informal treatment for mental disorder not available

'(1) This section applies where it appears to the responsible clinician that the conditions specified in subsection (3) are met in P's case. 
 (2) The responsible clinician must ensure that, for so long as those conditions appear to him to be met, treatment for mental disorder is not given to P, except in a case of urgency, unless it is authorised by or under Part II of the Mental Health Act 1983. 
 (3) The conditions are that— 
 (a) P is not capable of consenting to the treatment by virtue of a lack of capacity within the meaning of section 2 and there is no reasonable prospect that he will become capable of doing so, and 
 (l) he either— 
 (i) would resist the treatment if given, or 
 (ii) is at substantial risk of committing suicide or causing serious harm to other persons. 
 (4) For the purposes of this section, it is to be assumed that if P has at any time indicated that he does not want to receive treatment for mental disorder or particular treatment, he would resist such treatment.'.

New clause 8 - Duty to determine whether P is to be assessed

(1) The Secretary of State must, if requested to do so by any person, determine whether the conditions specified in section E (2) to (7) appear to be met in P's case. 
 (2) If the Secretary of State determines that those conditions appear to be so met, he must, as soon as practicable after making the determination— 
 (a) appoint a responsible clinician to act in respect of P for the purposes of this Part, and 
 (b) secure that P is assessed under section E by the responsible clinician.'.—

New clause 9 - Duty of hospital managers to request assessment of existing patient

'(1) Where— 
 (a) treatment for mental disorder is being provided to P at a hospital otherwise than in accordance with Part II of the Mental Health Act 1983, and 
 (b) it appears to the responsible clinician that the conditions specified in section E (2) to (7) appear to be met in P's case, 
 the managers of the hospital must request the Secretary of State to determine under section C(1) whether those conditions appear to be met. 
 (2) Where P is liable to assessment for admission or treatment under Part II of the Mental Health Act 1983 and it appears to the responsible clinician that the conditions specified in section E(2) to (7) appear to be met in P's case, the managers of the hospital to which P has been admitted must request the Secretary of State to determine under section C(1) whether those conditions appear to be met.'.

New clause 10 - Assessment for safeguards

'(1) The assessment of P under this section is for the purpose of determining whether the conditions specified in subsection (2) to (7) are met in P's case. 
 (2) The first condition is that P is aged 16 or over. 
 (3) The second condition is that P is suffering from a mental disorder within the meaning of section 1(1) of the Mental Health Act 1983. 
 (4) The third condition is that that mental disorder is of such a nature of degree as to warrant the provision of medical treatment to P. 
 (5) The fourth condition is that P is a resident patient at a hospital for the provision of treatment to him. 
 (6) The fifth condition is P is not capable of consenting to the treatment. 
 (7) the sixth condition is that the treatment can lawfully be provided to P without P being subject to the provisions of Part II of the Mental Health Act 1983. 
 (8) If the responsible clinician determines that any of those conditions is not met in P's case, P ceases to be a qualifying patient.'.

New clause 11 - Assessment: supplementary

'(1) The Secretary of State must secure that the assessment is made not later than the end of 28 days beginning with the day on which a responsible clinician is appointed for P. 
 (2) If because of exceptional circumstances it is impracticable to make the assessment within the 28 days, the Secretary of State must secure that it is made as soon as is practicable. 
 (3) The responsible clinician must make a record of— 
 (a) his determination under section E and reasons for it, and 
 (b) any exceptional circumstances to which subsection (2) applies.'.

New clause 12 - Medical Advisers

'The Medical Adviser for the purposes of this Act is a registered medical practitioner who is a member of the Expert Panel appointed by the Secretary of State.'.—

New clause 13 - Representation

'(1) As soon as practicable after appointing a responsible clinician for P, under section C, the Secretary of State must notify the local social services authority of the appointment. 
 (2) The authority must then, as soon as practicable— 
 (a) notify P of the help available from appropriate advocates under any arrangements existing within the hospital or the relevant local authority area, notwithstanding that P might not be deemed to be ''ordinarily resident'' within the relevant local authority area, 
 (b) notify P of what rights to apply to the court existing under section 48, the help available to obtain representation and the powers of the court, 
 (c) notify any carer, representative, the Independent Consultee, a donee of a lasting power of attorney granted by P, or a deputy appointed for P by the court of the help so available.'.—

New clause 14 - Role of representative

'(1) The responsible clinician for a qualifying patient, P, must ensure that one representative adopted or appointed by P— 
 (a) is consulted before medical treatment of any description is commenced, and 
 (b) is kept informed while medical treatment of any description continues, and 
 (c) is consulted before P is discharged or becomes a non-resident patient of the hospital. 
 (2) If it appears to the representative consulted that P, if he had been capable of doing so, would not have consented to medical treatment of a particular description being used (or being continued)— 
 (a) he must inform the responsible clinician, and 
 (b) the responsible clinician must then ensure that, except in a case of urgency, medical treatment of that description is not used (or continued).'.

New clause 15 - Preparation of care plan

'(1) the managers of a hospital at which medical treatment is provided to a qualifying patient, P, must secure that— 
 (a) a care plan is prepared for P by the responsible clinician, and 
 (b) the care plan is included in P's records. 
 (2) the managers must secure that the plan is prepared not later than the end of 28 days beginning with the day on which a responsible clinician is appointed for P. 
 (3) In preparing a plan for P, the responsible clinician must consult P and P's representative. 
 (4) A plan must— 
 (a) include the required information, and 
 (b) be prepared in the form prescribed by the Secretary of State in regulations. 
 (5) In this section, the ''required information'' means— 
 (a) a description of the medical treatment which is to be provided to P during the period for which the plan applies, and 
 (b) such other information relating to the care of the patient during that period as may be prescribed by the Secretary of State in regulations.'.

New clause 16 - Approval of care plan

'(1) The responsible clinician must, as soon as practicable after preparing a care plan, send a copy of it for approval to a person (the 
''medical adviser'') appointed by the Secretary of State for that purpose. 
 (2) The medical adviser must be a member of the Expert Panel who is a registered medical practitioner. 
 (3) The medical adviser must first— 
 (a) examine P, 
 (b) satisfy himself that section J(3) has been complied with, and 
 (c) discuss the treatment specified in the plan with the responsible clinician. 
 (4) If the medical adviser is satisfied that the treatment specified in the plan can lawfully be provided to P without P being subject to the provisions of Part II Mental Health Act 1983, he must approve the plan. 
 (5) If the medical adviser does not approve the plan within the time prescribed by the Secretary of State in regulations, the responsible clinician must apply to the court for approval of the plan. 
 (6) The responsible clinician must send a copy of the plan to P and to P's representative as soon as practicable after it is approved. 
 (7) A medical adviser may, for the purposes of discharging functions under this section, at any reasonable time— 
 (a) visit, interview and examine P in private, and 
 (b) require the production of and inspect any records relating to him which are kept by the responsible clinician.'.

New clause 17 - Amendment of care plan

'(1) The responsible clinician may amend P's care plan at any time. 
 (2) Sections H to K apply to an amended care plan as they apply to a care plan. 
 (3) If the responsible clinician amends P's care plan, the managers of the hospital at which P is resident must secure that the amended plan is included in P's records as soon as practicable after it is prepared.'.

New clause 18 - Review

'(1) A care plan for P must specify the date on or before which P's responsible clinician must carry out a review (the ''review date''). 
 (2) The first review date must be not more than six months after the day on which the plan is approved under section K. 
 (3) Each subsequent review date must be not more than six months after the previous one. 
 (4) P's representative may request a review at any time, but may not make more than one request in any 6 months. 
 (5) On each review the responsible clinician must consider— 
 (a) whether the conditions specified in section E are met, 
 (b) the date to be substituted in the care plan at the next review date, and 
 (c) whether the care plan should be otherwise amended. 
 (6) If the responsible clinician determines that any of the conditions under E are not met in P's case, P ceases to be a qualifying patient. 
 (7) The responsible clinician must inform P's representative in writing of the determinations made on any review and the reasons for them.'.

New clause 19 - Refusal of a request for review

'(1) If the responsible clinician refuses a request under section M(4) for a review, he must, if required to do so by P or his advocate or representative, refer his decision to a member of the Expert Panel who is a registered medical practitioner (the ''medical adviser''). 
 (2) If, on a reference under subsection (1), the medical adviser decides that the review ought to be carried out, the responsible clinician may either— 
 (a) carry out the review, or 
 (b) apply to the court. 
 (3) If— 
 (a) the responsible clinician fails to make a reference under subsection (1), 
 (b) the medical adviser agrees, on a reference under that subsection, with the decision not to carry out the review, or 
 (c) the responsible clinician fails to act in accordance with subsection (2), 
 P may apply to the court. 
 (4) On an application under subsection (2)(b) or (3), the court must determine either— 
 (a) that the responsible clinician must carry out the review, or 
 (b) that he is not required to carry out the review.'.

New clause 20 - Disputes about outcome of review

'(1) The responsible clinician must, if requested to do so by P's representative refer to the medical adviser appointed by the Secretary of State for that purpose any complaint made by P's representative as to the outcome of a review. 
 (2) If, on a reference under subsection (1) the complaint is not resolved within the prescribed time and the medical adviser upholds the complaint, the responsible clinician must apply to the court. 
 (3) If— 
 (a) the responsible clinician fails to make a reference under subsection (1), 
 (b) the complaint is not resolved within the prescribed time, and the medical adviser dismisses the complaint, or 
 (c) the responsible clinician fails to act in accordance with subsection 2, 
 P's representative may apply to the court. 
 (4) On an application under subsection (2) or (3), the court must, so far as relevant to the application, make a declaration either— 
 (a) that the determination of the responsible clinician in respect of that matter is approved, or 
 (b) that the determination of the responsible clinician in respect of that matter is not approved.'.

New clause 21 - Application to the court for discharge

'(1) An application may be made to the court by P or by his or her representative for an order requiring the managers of the hospital to discharge P. 
 (2) If the court is satisfied that P is being unlawfully detained at the hospital, it must make the order.'.

Tim Boswell: I have no objection in principle to clause 28, but discussing it paves the way for a debate on the new clauses. I do not intend to speak at length about them, but I want to say a little about the important interaction of this legislation with the mental health legislation that is promised and which, in parallel with our deliberations, is being considered in draft form by a scrutiny Committee. I also want to address the question of where a particular issue should be resolved.
 Anyone who has spent any time dealing with this matter knows that I am referring to the so-called Bournewood gap, which has been the subject of a determination by the European Court of Human Rights within the past month. That requires careful 
 analysis by the Minister of State, Department of Health, the hon. Member for Doncaster, Central (Ms Winterton) and her officials, and I know that Ministers are not super-people. 
 I should have graciously said that it is very nice to see that the Minister is now dealing with the debate. That is not meant to be derogatory to her colleague the Under-Secretary of State for Constitutional Affairs, the hon. Member for Tottenham (Mr. Lammy), but it changes the batting and the Department, which is important. I am sorry that my party cannot offer to do the same at present—at least not on its Front Bench. I will defer later to my hon. Friends, and in particular to my hon. Friend the Member for Tiverton and Honiton (Mrs. Browning); they will have more to contribute. 
 I have to admit to the Committee that I have undergone a slight conversion on this matter; I do not often admit to such experiences, but perhaps politicians should. My immediate reaction was to say that the matter ought to be dealt with under mental health legislation, because it is about detention. Let me explain that. I am only a layperson, but as I understand the Bournewood judgment the cardinal issues were: was the person detained, and was there was a process under which they were properly detained when it was necessary for them to be detained? Not unusually—the Minister will be familiar with judicial reviews in the United Kingdom system—the judgment in this case was very much about process. The judgment specifically stated that clinicians and medics had acted in good faith in the matter and—I suspect, although I cannot remember the exact reference—in the patient's best interests, but that a process was not in place. 
 If we are detaining people, we must have a process in place. The present mental health legislation now dates back over 20 years. Even if it is defective or needs updating, the cardinal provision of the Mental Health Act 1983 is a system for detention and safeguards in respect of the detained person; somebody can step in and make representations, and there is a process. 
 I defer to my hon. Friend's great knowledge of this matter, but as I understand it the difficulty with the Bournewood gap is that the person was not sectioned, to use the old-fashioned phrase; they were not detained compulsorily, either for their own good or for the good of other persons. This was a voluntary patient, who had no capacity, and the essence of the Government's case was that that person was detained on an argument of necessity. However, that would be displaced by clause 5 of this Bill, and the specific provisions for the various appointments, which we have also been discussing. The European Court felt that that was insufficient to deal with a position of detention. 
 My immediate reaction was that that was a mental health matter. It was buttressed by the prudential point that there is already a mental health review tribunal. There is a process—a mechanism—and the Minister's colleague, the Under-Secretary of State for Constitutional Affairs, did not want to overload the Court of Protection with a lot of detailed cases, particularly of a day-to-day or comparatively regular nature, because it would be better for it to deal with 
 issues essentially of life and death, which would arise only in exceptional cases; there are hundreds rather than thousands of them a year. That all seemed perfectly reasonable, and somebody whom I know who is involved in the law tended to advise along those grounds. 
 I must now say why I have changed my mind. As a result of advice from the Royal College of Psychiatrists and others, and of going back and reflecting on the matter, I now feel that it should be dealt with in this part of this Bill. I will start with the lower order reason for making that decision. There would clearly be a gap of a different kind if we did not address this matter in the Bill. 
 There is a reasonable presumption, which I do not seek to derail, that the Ministers will have their legislation on mental capacity in place by next spring. The Mental Health Bill is a year behind, for reasons that we need not go on at length about now. It is still being subjected to scrutiny and, subject to whatever decisions are taken by the business managers, it may not appear, and is not likely to become law, for some considerable time. 
 Therefore, there is a legislative gap to add to the Bournewood gap: there will be no response to the ECHR judgment unless and until we have changed the Mental Health Act. That is a lower order reason for proceeding, because it flags it up to the Minister—quite firmly, I hope—that there will be concerns if the matter that we are discussing is not covered. Decisions taken by clinicians in good faith will have to be taken with a rather shaky legal cover while that matter is being considered, and until it is tidied up. 
 A senior lawyer in another place, to whom I spoke last night, said that he was concerned because there might be other areas of the mental health legislation that urgently need tightening up anyway, even before a full mental health Bill. That, however, would not arise under clause 28. 
 As I said to the Minister, that was the lower order reason for my changing my mind as I reflected on the matter. The more substantial reason is that the main point about the Bill is the fact that it is about capacity and the best interests of the person involved.

Joan Humble: I am pleased that the hon. Gentleman has moved on to higher order issues. Surely one of the other failings in the process involved in the Bournewood gap is that the carers of Mr. L were not consulted or involved, and they were denied access to him. Yet, under this legislation, when the assessment of capacity and the person's best interests are being discussed, the carers, whether they are informal carers, family members or professional carers—as I understand was the case with Mr. L—would be part of the process. He would not therefore have languished for three and a half months in an institution without anyone being involved in determining that.

Tim Boswell: Yes. If I may say so, the hon. Lady has illuminated the point very well. Central to this issue—I
 should have added it to the list of good things in the Bill—is the built-in requirement for consultation; that would help. I will return to the subject in a moment, because we should not shy away from it, but even if we used the Bill and we thought that it was in a person's best interests for them to be voluntarily in some form of treatment—

Angela Browning: It might interest my hon. Friend and other Committee members to know that the carers in that case were paid carers. I shall read to the Committee a letter from them in which they continue to express concerns about the Bill; even as it is currently drafted, they would not have been included as people to be consulted.

Tim Boswell: That is a sobering point, and perhaps we will hear more about it in my hon. Friend's speech. It should be self-evident, even if we did not have the relevant legislation, that it is good practice to consult. It is distressing if that does not happen. It is another element that the ECHR took into account during their discussions.
 I was about to say to the hon. Member for Blackpool, North and Fleetwood (Mrs. Humble) that we must face the fact that there could be a clash between carer and clinician, however much consultation takes place. That would ultimately come before the Court of Protection, which would then determine the matter with regard to the regime of care and treatment, but might also have to consider, under this measure, the issue of detention. 
 I revisited the clauses that we have already dealt with—specifically, the famous clause 5, which would update the old doctrine of necessity and enable carers to take action. Later, the duties of people appointed as deputies are set out. Under clause 16, deputies would have powers to rule on personal welfare issues—on behalf of the court, in effect. Such issues would include where P is to live, for example. 
 I suppose that one could argue, and perhaps the Government would want to, that a decision about where P is to live would cover wherever they might be taken for treatment without being able to leave. The power to decide that would have been devolved to the deputy, just as, under clause 5, carers would be given very general powers—I shall not use the words ''general authority''. Clause 6 would limit such powers in the case of restraint, but they would not be taken away altogether. 
 I can understand the mindset that has emerged from what Ministers have said to date. Prior to the ECHR judgment, they could say that the Bill was about the overall approach to the needs and best interests of the person without capacity, and that there were general powers for carers, and specific powers for deputies to exercise on behalf of the court, which covered where the person should reside, if, in the judgment of the deputy, after consultation and all the other caveats, it was in their best interests. However, all that is cast into doubt by the ECHR judgment. Ministers must react to that, and the Bill would be the right place to do so, because they could build on some of the concepts. 
 I want to go back to something that I said to the hon. Member for Blackpool, North and Fleetwood a moment ago. First, not everybody with a mental problem has to be treated in hospital. One of the difficulties is that in mental health legislation we are talking about a detention ''sectioning'' someone, or whatever, to a mental health hospital or institution. That may not be appropriate. Secondly, this Bill, and all that it says about those engaged in taking decisions on behalf of a person, is about the overall best interests of the person, which will include courses of treatment, what is sensible and what safeguards there are. Arguably, such best interests could include personal safety or an assurance that the person will continue treatment until it has done its work. 
 To take an analogy from a rather different context, many of us are concerned that if mental patients are released into the community, they get slack with their medication and they go back to having problems. So it is perfectly reasonable to say that carers and clinicians need to look together at where the incapacitated person should live, be protected and receive complete treatment. That might be in their best interests. However, it might be seen as detention—not, of course, detention for an offence, but some kind of compulsory locking up or inhibiting of the person. We need to respond to that idea. 
 There is also the real-world issue of people with fluctuating capacity, particularly those with a mental illness. A GP might say to such a person, ''We think you need help. Would you like to go to this place and get some?'' While they had capacity, the person might voluntarily consent to that; they might have a mental illness condition, but they might still have mental capacity. How would it be if the news got around that they could go to such a place as a voluntary patient, but might never come out because somebody might detain them—what is more, detain them without the safeguards available under the Mental Health Act? That could act as a deterrent, which is one reason why I expressed concern before. 
 What we should do about this I am not certain, but Ministers need to get a grip on the issue now—I do not mean today, but during the passage of the Bill—and get a sensible response into the Bill. I do not think that that can wait indefinitely. In the interests of the people, and now that we have excited the interest of the European Court, I do not think that it would be wise to wait. The Bill is the best forum for dealing with the issue. 
 We must build on the concept of taking a holistic approach to someone's best interests, ensure the minimum intervention appropriate to secure a person's safety and welfare, and ensure the qualified nature of acts that can be done for them. As was discussed extensively this morning in a different context, we probably need some kind of independent certification by a third person—someone from outside who has no interest in the case—who must agree that something is in the person's best interests. On the analogy with the Mental Health Act, we may need a review procedure whereby that person is not permanently detained, and under which the case can 
 be reviewed. That would go some way to meeting the concerns expressed by the European Court and by carers. That would be a sensible incremental response, and this is the right Bill to deal with it at the earliest possible moment.

Angela Browning: I realise that many distinct areas are covered by new clauses 6 to 21, which I tabled, but as my hon. Friend the Member for Daventry (Mr. Boswell) outlined, the purpose of the new clauses is to use the Bill to close the Bournewood gap. As a House, we are in quite a lot of difficulty at the moment because of the two separate Bills running in tandem. We also have some difficulty in that the Bournewood judgment is relatively new, but the Government must acknowledge it in law. I appreciate that the Government will need to take best advice and consider the matter, but I am convinced that the Bill is the right vehicle for filling the Bournewood gap.
 Indeed, the Joint Committee, of which I was a member, made it clear in our recommendations to the Government that the Bill should close the Bournewood gap, but at that stage we had not yet heard the determination of the European Court. Over several years, and through the consideration of the draft Mental Health Bill, we have become aware that the Bournewood case has flagged up a problem, but until now it has been difficult to know exactly what we need to do. We now know what to do; the question is how we do it, and which Bill to use. That is at the heart of my new clauses. 
 Before I say any more, it might be appropriate to declare some interests; as many people know, I hold several positions in autism charities, including the National Autistic Society. I know the carers involved in the Bournewood case personally, and I have followed that case for some years. 
 It might also be helpful to identify the surroundings of the Bournewood case, because although it is of particular interest to people with autistic spectrum disorders, it goes wider than that. It brings within its scope a lot of people who would fall into the same category as Mr. L, a gentleman with autism in his 50s, who had lived for some years with paid carers as part of their extended family. He was taken to psychiatric hospital in July 1997 but was not allowed to leave. He remained there for some five months. He was deemed mentally incapable of consenting to treatment, and that meant that his detention in hospital was authorised under the common law, effectively on the basis of a single doctor's opinion. 
 The opinion was that Mr. L was suffering from a cyclical mood disorder, and that admission to hospital was in his best interests—a term that we have mentioned quite a bit in Committee. Therefore, there was no need to use a sectioning order under the existing mental health legislation. Through his carers, Mr. L took proceedings through the High Court to the House of Lords and then ultimately to the European Court. We have now heard the judgment, with which the Minister will be only too familiar. 
 It is not just people with autistic spectrum disorders who would find themselves in a similar situation. It 
 would extend to a great many people who lack capacity but are detained under the common law. My new clauses enjoy widespread support in the disability world, including that of the National Autistic Society. I must credit the Making Decisions Alliance, which has assisted me with the drafting of the clauses and in trying to see how best to fill the Bournewood gap. 
 The Joint Committee pointed out to Government on page 63 of its report the need to fill the Bournewood gap; indeed, the Minister gave evidence to our Committee. Nevertheless, having heard the Minister's evidence, we felt that a great deal more clarification was needed. At that time she was waiting for the European Court's decision, but in view of the Joint Committee's recommendations and the Government's response, the Minister should consider this Bill as the appropriate vehicle. 
 The Committee said at the time that it disagreed with Lord Filkin's assessment, in terms of recommending that consideration be given to making a statutory requirement for an independent second medical opinion. I was interested to hear yesterday, when I attended the Committee scrutinising the Mental Health Bill, that the Royal College of Psychiatrists supports a second opinion. We understand the weakness of a single doctor, as in the Bournewood case, taking a decision that, despite being taken in the best interests of the person concerned, was clearly wrong.

Tim Boswell: I in no sense dissent from the argument that my hon. Friend is developing, but does she not agree that it is important to draw a distinction between a clinical second opinion, which I agree is appropriate, and the representation of the person involved by an independent, possibly lay, advocate? That is a separate but equally important concern.

Angela Browning: Indeed, we are trying to put that on to the statute book, but the difficulty, as with all aspects of the Bill, is that individual circumstances are different. In the case of autism, it is widespread, particularly in provincial hospitals, for psychiatrists not to have a specialism in autism and therefore to make inappropriate judgments about a patient's treatment. This Committee should consider the statutory right to a second opinion, initiated either by the patient or by their carer. It was a strong recommendation of the scrutiny Committee when we considered the Bill.
 The consequences of Bournewood are far reaching. It is clear from the evidence that the Foreign and Commonwealth Office gave to the European Court of Human Rights on behalf of the Government in January last year that it anticipated that if the Court found in favour of Mr. L—which it did—the consequences for UK legislation would be profound. I am not allowed to read, but I shall summarise the representations made to the Court at the time. The Government anticipated that the consequences could involve thousands of patients who are currently not 
 subject to statutory procedures at all, and that they would come within the ambit of mental health. 
 I have huge concerns about that, as I assume the Government do, because they flagged it up as a potential problem. Now that we have heard the judgment, we must deal with the problem. Choosing which Bill to use to close the Bournewood gap is fundamental to the detail of meeting the requirements of the European Court of Human Rights—and, I would hope, those of this Committee. 
 We must look at the 2002 draft of the mental health legislation. Bournewood was before us then, but it was further down the pecking order in terms of the courts that were dealing with it. The Government attempted to close the Bournewood gap when they introduced the draft Mental Health Bill in 2002. We now have to consider the 2004 draft Mental Health Bill, but the Government have removed the bulk of that closure from the new draft. We are now left with having to decide whether to reintroduce it in the new draft Mental Health Bill or in this Bill. Will the Minister explain why it was thought appropriate to remove the closure from the 2002 draft? Was it in anticipation that the European Court judgment would go the other way? I do not know what was in the back of the Government's mind when they removed the closure from the draft that we are now dealing with, and it would be helpful to know why they did it. 
 Members of the Committee will recognise immediately that new clauses 6 to 21 are similar to the measures that the Government removed from the 2002 draft of the Mental Health Bill. They have been lifted for incorporation in the Mental Capacity Bill so as to reintroduce the closure in the context of this Bill. My hon. Friend has referred to the time scale. If matters proceed as we understand that they will, the Bill will receive Royal Assent by next spring, whereas the Mental Health Bill may follow in two or three years. We will therefore have to live with this Bill and the existing mental health legislation—which in itself will create a gap, because clearly the Government do not have the luxury of being able to delay dealing with the Bournewood gap until the Mental Health Bill is on the statute book. It will be an affront to the judgment of the European Court not to fill that gap, and this Bill is the appropriate vehicle. 
 The new clauses would address the elements of the Bournewood decision in the European Court. The Bournewood judgment stated that we cannot detain someone unless it is lawful, and that detention resting on common law necessity and the best interests criterion is not lawful. We must consider that, as well as the fact that lawful detention for treatment for mental disorders must comply with safeguards. I put it to the Committee that the new clauses would build those safeguards into the Bill. 
 I shall say a little more about the patient representative later, because that is important. The hon. Member for Blackpool, North and Fleetwood, who intervened in the speech by my hon. Friend the Member for Daventry, considered that the existing safeguards in the Bill would cover patient representatives. I beg to differ. We need to make that clearer and firmer. We also need to examine the 
 validation of a mental disorder and its treatment, with an independent second medical opinion, because that is what the European Court has said must we do. We need two medical practitioners, one of whom must be unconnected with the patient's treatment. Whether we consider such requirements of the European Court are good or bad, the Government have a duty to comply with the judgment, so it is important that we bring them within the scope of the Bill. 
 There must also be the facility to review the continuation of detention for treatment. That review process, too, must be clear and meet the European Court's requirements. We must review the legality of detention, and I hope that the new clauses will meet the requirements of the gap. As I said, the 2002 draft of the Mental Health Bill sought to protect patients who are treated for a mental disorder informally, but who lack mental capacity. The provisions that were dropped from the 2004 draft had been intended to cover the Bournewood case. In its judgment on the case, the European Court of Human Rights set down the same practical steps as are in new clauses 6 to 21, and the reasons why procedural protections are necessary to uphold the convention rights. 
 The Government have said that appropriate provision has been made in the Bill, but they need to put specifics behind the commitment now that the decision has been given in full. The judgment states, for example, that 
''the Court finds striking the lack of any fixed procedural rules by which the admission and detention of compliant incapacitated persons is conducted.''
 There is a need to state in statute the procedures that will cover that group of people. The judgment notes the significant contrast between the dearth of safeguards and earlier mental health legislation, and comments that the 
''this absence of procedural safeguards fails to protect against arbitrary deprivations of liberty on grounds of necessity and, consequently, to comply with the essential purpose of Article 5.1 of the Convention.''
 As I am not a lawyer, I am grateful for the advice of lawyers on how to do that. Perhaps the Minister will say today that the new clauses do not stand up legally, but I hope that they cover the scope of what the European Court said must now be put into UK law. 
 I will go through the new clauses as a group, rather than individually, to show how they cluster together and how they cover the European Court's recommendations. New clauses 15 and 17 deal with the requirements for and the review of the care plan. The following new clauses refer to the referral to an expert panel if a review is refused, and new clause 21 deals with application to the court for discharge. There must be a proper procedure and steps to prevent another case like the one at Bournewood: a chap was taken in, one person had all the say about his treatment and the duration of detention, and then it was left to third parties to take the procedures through the courts. Consider how long that case took: it went to the High Court, the House of Lords and the European Court. I am sure that it is not the intention of the Bill that all such cases should be treated in that 
 manner. We must have proper procedures and checks and balances so that we do not start with a blank sheet of paper at each step along the way if such a miscarriage of justice ever again took place. 
 Other issues dealt with in the new clauses include the validity of detention, a statutory scheme of care planning and safeguards. The Court said that the decision to detain someone for treatment had to be justified and that there had to be a proper, clear and transparent procedure to show how the decision had been made and on what basis professionals justified detention. Hon. Members will see from the headings of the new clauses that they deal with the duties to appoint a responsible clinician, to determine and assess P, and to determine whether he or she qualifies for safeguards. The safeguards should be set down in statute. 
 In the light of what the hon. Member for Blackpool, North and Fleetwood said, I shall deal with representation of the person presently. Even though I drafted the new clauses, I still have some concerns about who in any individual case will ultimately be seen to be the representative of the person concerned. We need to address that. Care planning, approval of the care plan, reviews of care plans, how to deal with disputes and the resolution of disputes about lawfulness of detention are also addressed in this cluster of new clauses. 
 New clause 12 aims to define medical advisers. I reiterate my recommendation to the Committee. I am glad to be able to say that it is endorsed by the Royal College of Psychiatrists. However, when it comes to medical advisers and professionals, I do not think that, in discussing this part of the Bill, we have focused enough on the need to include a statutory right to a second opinion. I shall not bat on ad nauseam about autism. The Committee has heard me doing that, and it is all on my website. If anybody cares to look at it, they can read of the appalling cases in which a medical person—a psychiatrist or other professional—has got it badly wrong for somebody with an autistic spectrum disorder. I have put it to the Government on several occasions that there should be a requirement for a second opinion to be sought from a professional who has greater knowledge and understanding of the condition. Such cases are complex and difficult, and when they are handled wrongly a lot of harm is done to people's lives. 
 Turning to access to a legal tribunal capable of deciding whether any detention is lawful, there has to be a process and a body to which representations can be made. If the process is ignored or not followed, there has to be a mechanism for challenging on behalf of the person who is detained the legality of treatment that has been given without consent. The carers in the Bournewood case were anxious to ensure that this Committee, in trying to close the Bournewood gap, did not ignore some of the complexities that arise in practice. The carers in the case are paid carers, and Mr. L lives with them as part of an extended family. The reason that they were thwarted at the beginning of his detention was that he had a living relative elsewhere who was not actively involved in his care; and because the carers were paid, as opposed to 
 voluntary, they slipped through the net. There has been a lot of discussion in Committee about the voluntary carer and the right to have somebody alongside who has day-to-day contact with the person about whom decisions are being made or whose capacity is being assessed. 
 I do not have an answer to that problem; I wish that I did. However, I put it to the Minister that when we draft legislation, we must take into account some of the rather strange quirks that occur when we think that we are doing the right thing. In the case that I outlined, the carers knew more about that person—Mr. L—than anybody else, and he knew them. They would have been the ideal people to form the bridge between him and the professionals, but they were frustrated in their efforts for a very long time after his detention.

Tim Boswell: Has my hon. Friend noticed the provisions in clause 32 in relation to research, which, according to my reading of them, would have precisely the same effect of excluding paid carers, however close to the person they were?[Mr. Tom Clarke in the Chair]

[Mr. Tom Clarke in the Chair]

Angela Browning: Yes, my hon. Friend is absolutely right. That is why I said that we needed to consider very carefully how we legislate for certain circumstances. We try with the best will in the world to do the right thing, but sometimes the result is very different. We must avoid that. It is difficult to legislate for a set of variables, but I draw the matter to the Committee's attention because we are bound to attempt to close the Bournewood gap in the context of this Bill. Even now, I am not convinced that we have got it right, notwithstanding the cluster of new clauses that are designed to do so. The problem has to do with language, and with putting in the Bill expressions such as ''nominated person or carer'', ''independent'' and ''an independent person''. All those things interrelate. I do not claim that it is easy to unravel all the terminology, but we have to make a good fist of it if we are not to find that precisely the same scenario arises again, and the very people who know the person best end up having to plough through the High Court.
 Under the Bill the Court of Protection would deal with the Bournewood case, but even with the court's enhanced powers, that causes me concern. It is for the Minister to give us some suggestion of the Government's reaction not just to my new clauses but to the whole issue of closing the Bournewood gap, and to say how we will do that while ensuring that a particular group—those who are detained but lack capacity—can be accommodated within the Bill. If the matter is left to be dealt with under the Mental Health Bill, the scenario that the Foreign and Commonwealth Office have, quite rightly, painted in respect of the European Court of Human Rights is that we will have thousands of those cases being brought under mental health legislation. That would be a disastrous way for us to proceed with mental health legislation, because a lot more cases would result in a lot more people being 
 sectioned and a lot of decisions being appealed against. The problem is not just the bureaucracy that that would create; it is a question of treating with basic humanity the people who would fall foul of that legislation. If we get the Mental Capacity Bill right, we can accommodate them in a much more humane and fair way. 
 By looking at the headings of the new clauses and considering the issues that need to be addressed following the European Court's judgment, I hope that I have persuaded the Minister, if not to accept my new clauses, then at least of the fact that this is the right Bill in which to deal with the issue. I hope that the Government will take those needs on board and agree that we should close the Bournewood gap in this Bill, even if it we have to do so later in our proceedings. If we try to close the gap in this Bill but do not get things right even after attempting to get it as right as we can, she will not find me jumping up and down criticising, because I realise that the matter is difficult and complex; but if we leave it to the Mental Health Bill we will have problems. The Government will not be complying with the European Court judgment, and to leave the matter to the Mental Health Bill would cause huge problems. From the small amount of evidence taken so far on the Mental Health Bill, it seems that the professionals feel that the Mental Capacity Bill is the right Bill for the issue, not the Mental Health Bill. 
 If we are forced to incorporate the provisions into the Mental Health Bill, it will not carry with it the support of many of the people who have to implement the proposals on the ground. That would be an additional difficulty when the legislation came on to the statute book. It is important that there is agreement between professionals, charitable bodies and those of us who take an interest in such things, and that we get the matter into the right Bill to begin with.

Paul Burstow: I rise to speak in support of the new clauses, and to pose one or two questions to the Minister. The purpose of this debate is to provide the Government with the opportunity to map out their thinking on how to deal with the decision of the European Court, and for us to hear about the road map that they propose to use to close the Bournewood gap. It is clear from what has been said and from various briefings the gap is growing as a result of the European Court's ruling. One of the points that struck me in many of the briefings that I have read during the past few days was that neither Bill would provide safeguards for people who do not resist treatment, but who have not consented to it or do not have the capacity to consent to it. We are trying to deal with that group of people, and we want the Minister to set out how, in law, the Government intend to do that. In the end, that was a key part of the concern that led the Court to rule as it did.
 Having listened to the debate and read the briefings from various organisations, it is still far from clear to me whether the Bill goes sufficiently far toward meeting the requirements of the Court. On balance, I 
 think that it does not and that there is a danger that, in attempting to answer the concerns of the Court, there has been a bringing together and confusion of issues. I am thinking of a clause that we shall deal with in considerable detail later, which deals with independent consultees. Committee members from all parties have tabled amendments to explore it further.

Angela Browning: But the carers in the Bournewood case would not have been regarded as independent consultees, because they were paid.

Paul Burstow: Absolutely. It seems to be a gap in the drafting of the Bill that that category of person, who would clearly have knowledge, would not be regarded as someone to consult. It is useful that that point has been teased out.

George Howarth: Will the hon. Gentleman give way?

Paul Burstow: Let me finish the point, and I shall be happy to. It would be useful if the Minister provided some clarification of whether the Government are minded to address the anomaly, so that the Bill clearly states that such people are one of the groups that should be consulted.

George Howarth: I have been carefully following the speeches of the hon. Member for Tiverton and Honiton and the hon. Gentleman. It occurs to me that the very problem that the hon. Lady identified—namely, that paid carers would be considered to have an interest of some kind—might also apply to an independent advocate. There would be a difference of degree, but that could be a further problem, which needs to be addressed.

Paul Burstow: The point about a potential pecuniary interest that might inform their judgment would undoubtedly have to be factored into the equation.

Tim Boswell: Will the hon. Gentleman give way?

Paul Burstow: Let me just finish my line of thought. Almost all the consultees identified in the Bill would have an interest—something would motivate their commitment. The Minister, rightly, keeps drawing us back to their overriding interest: the best interests test and whether they are acting in accordance with it.

Tim Boswell: Given the Government's healthy commitment to consultation and taking all relevant factors into account, it might well be sensible, and not onerous on a practical level, both to take account of the views of paid carers and to seek some independent person, completely outside the system, to make an independent, disinterested judgment on behalf of the person concerned.

Paul Burstow: I shall treat that intervention as an opportunity to return to the tack that I was on before the first of that sequence of interventions. One of the points made about clause 34 is relevant to this debate about the Bournewood gap and the new clauses. In some ways, clause 34 conflates two different things: the role of advocacy, which I do not think the clause adequately answers, with the need for expert professional second opinions, whether medical or otherwise. Those two things do not fit comfortably together. The Government, perhaps for understandable reasons, may be driven by a need to
 keep an eye on what the Treasury might think about such things. They may be considering the resource implications, which should not run away from them.
 I was struck by the comments of the hon. Member for Tiverton and Honiton about what the Foreign and Commonwealth Office's submission of evidence to the Court said about the resource implications. Evidence was also given to the House of Lords on this matter, albeit back in 1998, that drew on information from the Mental Health Act Commission and the Department of Health. It would be helpful to get new figures on the record today, but it was estimated then that 13,000 patients were detained under the Mental Health Act 1983 on any one day. If in-patients who lacked capacity were treated informally, that would create an additional 22,000 patients to whom the Mental Health Act safeguards would apply. Annually, that would create about 48,000 admissions under the Act. It would be useful to get some sense of whether those figures still roughly define the parameters of the current debate, and if they do not, why not. One point made in some briefings is that there is a growing number of people with dementias and that they may fall within the ambit of the provision. I am not convinced that that is a good enough reason not to try to clarify the matter. 
 It is useful that this Committee is in sitting at the same time as the Joint Committee scrutinising the draft Mental Health Bill. Several members of this Committee are also on that Committee. I have been looking at some of the oral evidence that they have heard so far. Questions have rightly been asked about how the Bournewood gap can be closed. Two individuals who are very eminent in this area of law and practice have recently appeared before them—Professor Richardson and Mr. Heginbotham. Both were asked whether this Bill and the draft Mental Health Bill in their current forms adequately close the gap. Professor Richardson said: 
''I am really troubled about the relationship between the two Bills and it would seem as if the safeguards provided within the Mental Capacity Bill are not going to be sufficient to meet the court's requirements''.
 She concluded: 
''I am worried that the relationship between these two terribly important Bills has not been properly worked out.''
 Mr. Heginbotham acknowledged that this was still ''a grey area'', and he gave the example of 
''a young person with schizophrenia who has lost capacity and whose parents have, through various procedures, had that person come under the Court of Protection, but who could . . . be treated under one Bill or the other depending upon circumstances.''
 He said that a game of ping-pong starts being played with the individual and their life about which legislation might apply at any one time. That is another reason why it is important to be as clear as possible about precisely how the gap is to be closed. 
 I want the Minister to say whether the work being done in the Department of Health and the Department for Constitutional Affairs is intended to deliver further amendments to the Mental Capacity Bill, either in this House or in the other place, so that problems are dealt with in the context of this legislation, or whether the intention is to use the process of scrutiny of the draft 
 Mental Health Bill in such a way that they are dealt with under that legislation. My preference—for what it is worth, and I accept that it might not be worth anything—is for this to be dealt with in the context of the Mental Capacity Bill, because the sooner the gap is closed, the sooner we can guarantee the rights of this group of people, which are not currently properly protected and reflected in the law of the land, according to the Court ruling.

Rosie Winterton: I am a little thrown, Mr. Clarke; I was going to welcome Mr. Cran to the Chair and say how pleased I am to be serving under his chairmanship, but as he is not present I cannot do that. You might like to pass my welcome on to him, Mr. Clarke, and in the meantime I will say what a great pleasure it is to be serving under your chairmanship, however temporary that proves to be.
 Clause 28 deals with the interface between the Mental Health Act 1983 and the Mental Capacity Bill. It is primarily a technical provision to ensure that there are not two overlapping statutory provisions relating to the same clinical decisions. When patients are detained for assessment or treatment under the 1983 Act, that Act provides the authority for them to be treated for their mental disorder in circumstances when they lack the capacity to consent. It is therefore unnecessary and potentially confusing for the Bill to deal separately with the same decisions. The clause also ensures that the procedural safeguards set out in part 4 of the 1983 Act will take precedence and must be followed when treating patients to whom that part applies. 
 As right hon. and hon. Members know, the Bill has a broad scope. It provides an overarching legal framework for a broad range of adults who may lack capacity and are unable to make decisions for themselves. It covers all areas of daily life, whereas the 1983 Act is more narrowly focused on a limited group of people and provides legal authority for the treatment without consent of people with a serious mental disorder in circumstances in which it is warranted by the nature or degree of their illness and the seriousness of the risk to themselves or to others. 
 In addition, the 1983 Act deals only with treatments for a mental disorder. A person detained under the Act may also lack capacity in relation to other forms of medical treatment or care. At present, decisions about other treatment are taken under the common law doctrine of necessity. In future, they will be taken in accordance with the Mental Capacity Bill.

[Mr. James Cran in the Chair]
 The Bournewood gap has exercised the hon. Members for Daventry, for Sutton and Cheam (Mr. Burstow) and for Tiverton and Honiton. The amendments, as the hon. Lady pointed out, set out to establish new safeguards for hospital in-patients receiving treatment for mental disorder in their best interests under the provisions of the Bill. Those safeguards include a personal representative with the right to refuse treatment to which a patient would object and a care 
 plan approved by an independent medical adviser. There would also be a right to refer certain disputes to the Court of Protection. As the hon. Lady said, the clauses are modelled on part 5 of the 2002 consultation draft of the Mental Health Bill. 
 Although the hon. Lady has been careful to revise the new clauses so that they fit into the framework of this very different Bill, there are inevitably some technical problems. I shall not dwell on those. It is also important to remember that part 5 of the 2002 draft Mental Health Bill was drafted before we had the Mental Capacity Bill. It provided extensive safeguards, as we have heard, for a small group of patients, but offered nothing at all for others who lack capacity. Hon. Members have asked why we considered changes between the Mental Health Bill and this Bill. We thought that once we had a Mental Capacity Bill, it would be appropriate for safeguards for one group of patients to be integrated and consistent with those proposed for all others who lack capacity. Furthermore, part 5 of the previous Bill was drafted before the recent European Court of Human Rights judgment in the Bournewood case. 
 Perhaps I could give a little background to that case. The hon. Member for Daventry outlined it, but I think that it will be helpful if I set it out also. As many right hon. and hon. Members will recall, the case concerned Mr. L, who had autism and learning disabilities and was admitted to Bournewood hospital for psychiatric treatment in his best interests under the common law doctrine of necessity. As he did not resist treatment, he was not formally detained under the Mental Health Act. That was in line with standard practice. 
 A case was brought on behalf of Mr. L in the domestic courts, claiming that his detention was unlawful. However, in 1998 the House of Lords found that he had not, in fact, been detained and the case was then taken to the European Court of Human Rights. Its judgment, which was delivered on 5 October this year, found that Mr. L had been deprived of his liberty for the purposes of the European convention on human rights. 
 Furthermore, the Court found that the deprivation of liberty was unlawful under article 5.1 of the convention because of a lack of procedural safeguards surrounding his admission and continued deprivation of liberty. In the Court's view, the lack of such safeguards failed to protect him against the risk of arbitrary deprivation of liberty. In particular—the hon. Member for Tiverton and Honiton referred to this—it did not question the good faith of the doctors involved. However, it was concerned that the common law allowed professionals to take 
''full control of the liberty and treatment of a vulnerable patient solely on the basis of their own clinical assessments.''
 The Court also found that there that had been a breach of article 5.4 of the convention in that, at the time, judicial review did not provide the patient with an adequate means to challenge his deprivation of liberty. Clearly, that is an important judgment with significant ramifications. 
 The first point to make is that the case does not concern the treatment and care of incapacitated patients generally. It is concerned only with cases of deprivation of liberty. The Court has made it clear that whether someone is in fact deprived of liberty depends on the particular circumstances of the case. 
 Secondly, it should be also remembered that the Court was dealing with the law as it stood in 1997. Accordingly, the Government's view is that the Human Rights Act 1998 has already remedied the breach of article 5.4; there are now proper means by which someone in Mr. L's position may challenge his deprivation of liberty—through judicial review. 
 However, there is no doubt that we still lack sufficient procedural safeguards to prevent further breaches of article 5.1 in cases where patients are, in effect, deprived of their liberty in their best interests. That does not mean that such patients must be detained under the Mental Health Act 1983, provided other appropriate safeguards are available. Indeed, in some cases it may not be legally possible to use that Act, because it can be used only where strict criteria are met. 
 Therefore, even in those cases where the Mental Health Act might be relevant, it is not our intention that patients who lack capacity but who are compliant with treatment should automatically be detained under the Act. However, as I have said, we accept that further procedural safeguards are required for patients who are not formally detained, but who are, in effect, deprived of their liberty. We do not consider that those safeguards need to be identical to those in the Mental Health Act, but, despite the many improvements that it contains, including the important new protection of an independent consultee for the most vulnerable people, we accept that the Mental Capacity Bill may not, by itself, deliver all the necessary safeguards.

Angela Browning: While the Minister is talking about safeguards, does she accept that the requirements of the Mental Health Bill should have a read-across under the Mental Capacity Bill, such as a care plan by a doctor and independent supervision? They are built into the safeguards of mental health and need to be built into the Bill, too.

Rosie Winterton: We shall consider all aspects of the judgment and deliver the appropriate safeguards as soon as possible. I must emphasise, however, that, before we can do that safely, we need to consult widely with interested parties, including representative groups, the NHS and local authorities. It is important that we design effective and proportionate procedural safeguards that are deliverable in practice.

Tim Boswell: I am following the Minister's closely-argued case with interest and a good deal of sympathy, because she is responding genuinely to the concerns that have been expressed. If she is minded to set up a generous consultation period fairly soon, does she accept that it could be practicable to consider building in the necessary provisions at a late stage, possibly while the Bill is under consideration in another place? The worries that have been expressed by my hon. Friend the Member for Tiverton and Honiton and
 others are real and, as the hon. Lady said, we need to get on with matters as soon as possible.

Rosie Winterton: As I said, we are moving quickly towards consultation, but with regard to the new clauses tabled by the hon. Member for Tiverton and Honiton it would be premature at this stage to assume that the safeguards that we might consider necessary would be along the lines of those new clauses. They were drafted in a different era because of the changes that I have outlined, such as those under the Human Rights Act.
 When the proposals appeared originally in the draft Mental Health Bill, they were designed to provide additional safeguards for a group of informal patients as a matter of policy. They were not designed to provide procedural safeguards to protect patients from arbitrary deprivation of liberty because, at that time, there was no reason under domestic law to think that such patients were being deprived of their liberty. 
 For that reason, the proposals deal only with the position of patients who have already been admitted to hospital and do not provide procedures relating to admission itself. Even though they have been revised by the hon. Member for Tiverton and Honiton, they still would not address such issues in the most effective way. I accept the spirit of the contributions made by members of the Committee and I want to give the assurance that we are consulting as quickly as possible on how we can ensure that procedural safeguards are in place, but at this stage it would be difficult to give an exact date for when we will introduce the new safeguards.

Paul Burstow: When the Minister took the intervention from the hon. Member for Daventry, she gave part of the answer that I was about to seek. Just to be absolutely clear about her response, is it her view that it would be desirable to undertake the consultation at a pace that allowed further consideration of amendments tabled by the Government in the other place?

Rosie Winterton: I would not rule that out entirely. It is important that we get this right, as there are some vast implications, and it will not be as easy as one may think. As I said, simply taking part 5 from the old draft and putting it in the Bill will not cover what we need to do.

Angela Browning: I want to flag it up that there is some uncertainty about whether the European Court, when it considered its judgment—obviously, much of this goes over a very long time—was under the impression, as it appears from that judgment, that the provisions included in the 2002 Mental Health Bill were still current. In fact, they have been dropped. I am looking for a replication in this Bill of the safeguards that were in the 2002 Bill. I have a feeling that nobody told the European Court that in fact the section had been dropped from the legislation.

Rosie Winterton: I am not sure that I can comment fully on that. [Interruption.] As I understand it, we did tell the Court—saved by the bell! That leads me to re-emphasise how important it is that we carefully consider the judgment and its implications, and consult properly. Of course, as soon as we can, we
 will introduce procedural safeguards, as we are required to do. I hope that gives some reassurance to the Committee that we will consider the matter, consult on it and introduce any appropriate changes as soon as we can, and that, in the light of what I have said, the hon. Member for Tiverton and Honiton will withdraw the new clauses.

James Cran: The hon. Lady is not required to do that.

Angela Browning: Thank you, Mr. Cran. I recognise the complexity of the issue and the time scale that the Government have had in which to respond. Clearly, they will need to consult. However, we have not had a definitive reply from the Minister as to whether she intends to close the Bournewood gap through the Mental Capacity Bill. I would like that reassurance from her, Mr. Cran, before agreeing not to press the new clauses.

Rosie Winterton: I can say only that I would not rule out such a provision entirely, but, frankly, if we cannot find a form that will work, it would be wrong to say that it would definitely be introduced in time. I cannot say any more than that at this stage. I feel very strongly that we must get this right—it is important to a group of vulnerable people. If we do not, there would be enormous repercussions. It would be wrong to work to a timetable that does not enable us to get the provision right.

Tim Boswell: The Minister is doing her best with the Committee: she has been put on a very sharp point and I do not intend to prolong her agony. Given the concerns that have been expressed—and utterly against my normal preferences, I hasten to say—will she at least consider whether it might be possible to take powers under the Bill to make regulations that would be informed by the principles and broad approach of this legislation as set out in the debate? It may be possible at a later stage to come back with the details. Of course, if the regulations were not appropriate, they could be modified. I do not make that suggestion lightly or easily, as I would much rather see the provision in the Bill, but will she at least bear it in mind?

Rosie Winterton: I will certainly bear that suggestion in mind. I am quite happy to come back on that.

Angela Browning: I must put on record that I totally disagree with my hon. Friend the Member for Daventry. I want the provision in the Bill.

Rosie Winterton: I will look into the possibility of regulations, but it is important that we have the right vehicle for delivering the safeguards that we need.

James Cran: For the avoidance of doubt, there is no need for you to move any of the new clauses at this point, Mrs. Browning.
 Question put and agreed to. 
 Clause 28 ordered to stand part of the Bill.

Clause 29 - Voting rights

Tim Boswell: I beg to move amendment No. 40, in
clause 29, page 16, line 20, leave out 'for any public office'.
 This may be a less taxing issue for the Committee than the new clauses that we discussed earlier. This is simply a probing amendment. I notice that the clause seeks to avoid any suggestion that someone could vote on behalf of a person who lacked capacity, or use such a person's rights on their own behalf. 
 I have two anomalies in mind. First, I think that I am right in saying that persons with a mental illness but not lacking mental capacity are able to vote. We need not debate that here, but it would be useful if the Minister confirmed that. Secondly, in relation to private matters, a decision to be taken—on participating in an election as a shareholder on behalf of the person lacking capacity, for example—may, at one level, be even more momentous than the decision to participate in a general election or referendum. 
 Somewhat as an afterthought, I would like the Minister's assurance that the clause is so drafted as to cover the class of ''any public election'' or involvement. We are given a definition of ''referendum'' in the clause, and we know on the whole what elections for ''any public office'' entail, because all of us are involved in them. However, consultations locally, expressions of opinion, town polls and so on might not be covered, and it is important that the Minister briefly turns aside from our major considerations today to consider these nuts and bolts issues.

David Lammy: Clause 29 makes it clear that voting on behalf of others in elections for public office is excluded from the remit of the Bill. Voting in elections for public office requires that the voter be able to decide who he would like to vote for, probably based on the candidate's position, or various issues and policies that require some analysis. It would be difficult to determine what the opinion of the person who lacks capacity would have been if they had had the capacity to use information on the proposed office holder to come to a decision on whether to vote for him. No one would ever be able to check whether the proxy acted according to best interests, or simply voted in line with his own political persuasions.
 The amendment would exclude voting in elections other than those for public office from the remit of the Bill. I reassure the hon. Gentleman that the words ''for any public office'' make absolutely clear the type of elections to which we are referring, which include parliamentary elections and local council elections. The removal of those words might cause confusion. Without them, the clause could cover elections held by private clubs or organisations, and it is right that they are able to set their own rules and election procedures. We do not believe that elections other than those for public office should be excluded from the remit of the Bill. It must be for those clubs to regulate themselves. 
 I will take further advice and write to the hon. Gentleman on the specific question about mental illness and its effect in relation to an election. I hope that on that basis he will be able to withdraw the amendment.

Tim Boswell: I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn. 
 Question proposed, That the clause stand part of the Bill.

Paul Burstow: I listened to the exchange between the Minister and the hon. Member for Daventry and I wanted to ensure that I was clear in my understanding about a question. As a consequence of the clause, would a person who was able to take part in a public election and cast a vote, not be able to avail themselves of the proxy voting arrangements that exist in other legislation? In those circumstances, would they be able to have a proxy vote? Does this exclude the category of person that this measure is trying to deal with from being able to do that? I want to be clear whether proxy votes would still be possible in that context.

David Lammy: It is my understanding that the clause would exclude them from that proxy vote. I hope that my officials agree with me—it appears that they do.
 Question put and agreed to. 
 Clause 29 ordered to stand part of the Bill.

Clause 30 - Research

Tim Boswell: I beg to move amendment No. 41, in
clause 30, page 16, line 31, after '31', insert— 
 '(aa) in conformity with an advance decision to permit the carrying out of research on P made while P had capacity, and'.

James Cran: With this it will be convenient to discuss the following amendments: No. 42, in
clause 30, page 16, line 37, leave out subsection (3).
 No. 43, in 
clause 30, page 17, line 1, leave out subsection (5).
 No. 178, in 
clause 31, page 17, line 17, leave out subsection (3) and insert— 
 '(3) Research shall only be carried out if research of a similar nature cannot be carried out on an adult who is capable in relation to such a decision.'.
 No. 179, in 
clause 31, page 17, line 21, after 'to', insert 'provide real and direct.'.
 No. 44, in 
clause 31, page 17, line 23, leave out paragraph (b).
 No. 180, in 
clause 31, page 17, line 27, leave out paragraph (a), and insert 
 'that it entails no risk to P or that'.

Tim Boswell: Welcome back to the Chair, Mr. Cran.
 I am deeply relieved that the officials agree with their Minister, even if my hon. Friend the Member for Tiverton and Honiton had a little disagreement with me. It was about procedure rather than substance, because we all want to get on with discussing the Bournewood gap, but not in relation to these 
 particular amendments. However, some of the issues about consent, safeguards and the necessary process are as germane to the clauses that we are discussing as they were to that matter. 
 The Minister will know that these clauses are new clauses in the sense that they have come in since the Joint Committee's report, in response to its recommendation that research issues should be handled, rather than being clauses that have been resurrected from past mental health Bills because of concerns that were expressed at the time. Nevertheless, as I said on Second Reading, some of the issues of principles here give me the greatest difficulty that I have about the Bill. I remain to be convinced whether I can accept them and, if so, in what form. 
 The group of amendments is rather general, so I will start by setting one or two general points in context. Let us think about what has been done in the name of research, even through the necessary procedures that are internal to the control of that research such as research ethics committees, which have stretched the doctrine of necessity to its limit. 
 People can well imagine a situation in which somebody's loved grandparent has a stroke, is lying in hospital and a doctor comes along and asks the grandchild whether they can carry out tests on that person. That would be a distressing situation for everyone. There is probably a degree of moral encouragement to do that, because it may be good for granny—it could be argued on those grounds. Even if granny could not benefit, because she was by now past it, perhaps somebody else, or somebody else's granny, might benefit. That is not an unworthy set of human suggestions. We would probably have to say that, in the absence of legislation of this kind, there is no framework to regulate that kind of thing, and some undesirable things have happened. That leads me to observe that the work of research ethics committees—in relation to this and other types of research, and whether carried out on human subjects with consent, animals or whatever—is an important safeguard. 
 Those of us who have had explained the procedures, the external validation and the protocols that have to be found know that there is no question but that it is taken extremely seriously. I would not wish to signal that people are in some way getting up to wilful malpractice or resorting to practices of which we would be ashamed in principle. That is one important safeguard. The second is set out in the Helsinki convention—the Minister may be more au fait with that than many of us on the Committee. It provides a broad framework within which the issue should be addressed. I take comfort from that, although I warn the Minister that there is a bit of a sucker punch to come in a moment. 
 I consulted with the Disability Rights Commission on the matter only yesterday because of something that was drawn to my attention. It is only fair to quote what was said on the general point. That was: 
''Generally however, the DRC believes that the Government has encompassed the Helsinki convention on research within the Bill and we think this is reasonably sound.''
 That is a fair endorsement, and I am sure that the Minister would want the measures to be endorsed. It was also observed to me recently, when I took advice on the matter, that such processes are going on all over Europe. I asked the expert I was consulting whether we were ahead or behind, and the answer was ''probably ahead''. 
 The civilised world is, as it were, looking at this. There are concerns, and they need to be addressed. There is also an explicit safeguard in the Bill that is already explicit in the practice of research ethics scrutiny in this country. That is entirely proper. Let me say, before anybody gets the wrong idea, that the research should be specific to the person involved. There is no question of taking persons lacking mental capacity, exploiting their lack of mental capacity, and then saying—sadly all members of the Committee can imagine analogies—that these are Untermenschen, people whom we can now use to find out something else that we want to know. That has been done too many times in the last century, and we do not want to see anything like it. I would be the last person to suggest either that it is encompassed in current practice in Britain or in most other countries, or that it would be in any sense facilitated by this Bill. It is absolutely outside it. It has happened in western, democratic countries, as the Minister will know, but we have no time for it. Equally, we should not excite or alarm people into suggesting that it is now taking place. 
 Having said that, there are some matters of concern in the clauses. The Minister was silent during the exchanges that we had with her counterpart, the Under-Secretary of State for Constitutional Affairs, the hon. Member for Tottenham, in relation to principles and best interests, which we have discussed extensively. One assurance that I received from him was that the principles of clause 1 inform the whole Bill. He gave some explanation as to how they would be taken into account. If one considers clause 30, it is difficult to argue that the principle of best interests, which kicks in when a person lacks mental capacity, is in any way waived by it. The principle of best interests must continue in this clause; it cannot be taken out. 
 There is an argument involving clause 31, which amendment No. 44 addresses by deleting subsection (4)(b). Subsection (4)(a) states that the objectives of the research might be to 
''have the potential to benefit P without imposing on P a burden that is disproportionate to the potential benefit''.
 That is perfectly reasonable, and consistent with the best interests principle. However, paragraph (b), which is disjunctive to paragraph (a) as it is related to it by an ''or'' rather than an ''and'', states that the research might 
''be intended to provide knowledge of the causes or treatment of, or of the care of persons affected by, the same or a similar condition.''
 Therefore, it would be specific to the condition that the person had, but might not be to their benefit. This must be reconciled with the principles in clause 1. It goes to the heart of a lot of concerns. We cannot waive the best interests principle. 
 I turn to my second point—I warned the Minister of a sucker punch to come. I consulted the Disability Rights Commission because of submissions I received from the I Decide coalition and other interested parties in relation to the Disability Discrimination Act 1995. As the Minister knows, I could weary the Committee talking about that, but I have no intention of doing so. However, if under clause 30 we were to produce, even unwittingly, a regime that in terms of consenting to research is less protective of the interests of those who are disabled because they lack mental capacity than it is of persons with capacity—in other words, if we were to open a gap so that persons who lacked capacity could be made subject to procedures that they would not necessarily experience if they had capacity—we would have a problem, in terms of both disability legislation and the European convention, with discrimination issues. We must not get into that position. 
 I gave the Minister formal notice that I wanted to raise the matter that my third point addresses. I have not researched this as much as I should, but I am anxious that any regime we adopt be congruent with the Human Tissue Bill, which is being considered in another place. Above all, we cannot have a situation in which living persons who lack mental capacity, albeit they have a decision maker on their behalf, have to undergo more intrusive procedures than might be permitted on cadavers with the consent of the dead person's family or otherwise. The level of safeguards must be at least equivalent, if not higher. 
 I want to explain the biggest concern I had when I initially read these clauses. Lot of debates about donor cards have arisen as a result of private Member's legislation introduced by the hon. Member for Oxford, West and Abingdon (Dr. Harris). I carry a donor card; I suspect that many Committee members do, too. It is an advance decision of a kind. Many of us would probably be prepared to acknowledge that having a presumed consent to donation would be very convenient and might be in the best interests of medical research and the availability of organs. However, we are holding back from that on the principle of informed consent. We do not feel that it should be presumed that an adult has given consent simply because they have not not given consent. There is a danger when a person lacks capacity and they are not in a position any longer to make their own decision; nobody should be able to take a decision on their behalf that fails to meet the best interests principle. 
 I hope I have made clear the sort of groundwork from which I approach this matter and the areas in which I have genuine concerns. They have been mirrored in many of the representations made to us. 
 Amendment No. 41 is the easiest proposal and the Minister might say that it is redundant, but it would provide that research would be all right if it conformed to an advance decision made while P had capacity to permit the carrying out of research on P. In other words, it would extend the earlier provisions on advance decisions to include research, a principle that is not objectionable. Amendment No. 42 would 
 leave out subsection (3) and amendment No. 43 subsection (5), both of which relate to clinical trials regulations. Not all of us are expert on the clinical trials regulations specified under the Bill. We do not know exactly how they work, whether the safeguards are similar and whether the principles that I have set out, including the best interests principle, operate in the same way across those regulations. If they do not, there could be a difficulty. 
 Amendment No. 44 would strike out the alternative test. Under clause 31(4)(a), the research must have the ''potential to benefit P''. The alternative test under clause 31(4)(b) is that the research must provide general knowledge of the subject. I am not caricaturing the provision or suggesting that it is way beyond the pale; it is about people researching into Alzheimer's on an Alzheimer's subject, but it is arguable whether that is in the person's best interests. I wish to bring two other considerations to the Committee's attention, the first of which is urgency.

Joan Humble: The hon. Gentleman is making an interesting presentation, but the best interests test is deliberately not phrased as the ''best personal interests''. We have had much debate about that. I want to throw a suggestion into the pot. The hon. Gentleman gave an example of an Alzheimer's sufferer. If the research was wide-ranging research, examining the causes of mental incapacity, does he consider that that could comply with the general best interests test, even though it might not be in the personal best interests of the individual because he is beyond that?

Tim Boswell: I found it difficult to follow that argument, although I understand why the hon. Lady made it. She is acknowledging the difficulty under the clause. We can either work on the basis that the best interests of the person concerned means what it says it does and legal practice, which is that person and no other person, or we can take the view that there is a general good that transcends that. Let us consider the scheme of the Bill. If we start with the presumption of mental capacity, people may make advance decisions that are contrary to their best interests. However, when they lose capacity, no one is provided under the principles of the Bill with a facility for making decisions for them that would be contrary to their best interests. That is the nature of my concern about the matter and where a difficulty arises.

Angela Browning: We had a lot of deliberation about such matters in the Joint Committee. My hon. Friend will be aware that the Scottish legislation states that the research must be of real and direct benefit to the adult. We heard evidence from Dr. Lyons, who said that that was a difficulty because if the research was of real and direct benefit to individuals—

Rosie Winterton: They should be having it anyway.

Angela Browning: Yes, because it would not be research, but treatment. A difficulty arises with the definition of research and whether it is someone's best interests.

Tim Boswell: Of course there is a difficulty; the inference is that in the end some cases might have to be
 resolved by the court. I am conscious that practice that has been ill defined in the past and many such things have taken place. We seek to regularise practice in a way that is congruent with the rights of the individual—indeed, their rights under the convention—as well as with our general wish to support their best interests and to provide a regime under which such support can be provided.
 I do not have them before me, but Birmingham university and others have made powerful representations about urgent research, which say that we might effectively stop the research process by imposing restrictions. I understand the concerns about that; I also understand the concerns about achieving the equivalent level of safeguard if there is urgency. Many years ago, I had experience of a family member with a head injury. I did not get to know about it immediately, and was not even in the same country until some time after the event. However, I realised the difficulties involved. The issue is difficult. One does not want to stop all research, or make the system inflexible, but there are issues of principle that are difficult to run away from. 
 The other technical issue of concern is about whether research is intrusive. I am not sure that that would be a useful test either. The Government are clearly uncomfortable about the issue and talk about the research not involving risk, for example. Additional safeguards are set out in clause 33, which would enable the subject, if they flinch and indicate pain or distress, to stop the trial. In fairness, such safeguards exist already in research protocols; I am not suggesting that they do not. However, I am not sure that trying to rewrite on the basis of what might be termed passive, rather than active, research would be acceptable. 
 I do not believe that one can ever breach the best interests test; we need to test whatever we come up with against that. There are wider interests, and we have to establish how they can be reconciled. Personally, I feel relatively happy about tests that involve observation or are incidental to another test that is required for therapeutic reasons. If somebody was having a blood test for one purpose, and it was possible to take some cells from that procedure and use them for another purpose—for example, for investigating the causes or other aspects of Alzheimer's disease—I do not think that that would be objectionable in principle or practice. That might be a way forward, but anything that could involve even a little bit of pain or distress would be very difficult to reconcile with best interests. We have to look hard at how we are to deal with that. If one is honest, and the Government might have wanted to look at the issue in this way, one might say that the best interests test is too restrictive. I hope that in practice most of the issues can be resolved. 
 In conclusion, I offer the Minister one thought, which is about an aspect of best interests that we have not debated, although we have debated nearly everything else about that issue. Clearly, one does not want to harm the individual—indeed, that would not be consistent with the doctor's professional oath. Clearly, one wants to promote the best interests of the 
 individual, because that is the cardinal principle of the Bill. From time to time, acts will take place that will be difficult to classify as being in a person's best interests or otherwise. They may be neutral acts that do not damage or automatically benefit the individual. However, an individual who is alive, even if they do not have capacity, has to live somewhere. They are alive, breathing and carrying out involuntary actions. It may be that we will come to a point at which we are able to say that some things congruent with the research protocols could be carried out because they would not damage the individual, and that we would let them take place because they were not inconsistent with the individual's best interests. I am using a double negative, but I think that the Minister will understand. 
 I return to my central point about breaching the best interests test, there is a second aspect to it. If we are to go down this road—perhaps further reflection in the light of the Minister's response is needed at a later stage of the Bill—we must also look quite hard at the safeguards that are built into the process now. There will be urgent cases, and I am conscious of the difficulties that clinicians face, not only in their research but from legal challenges to their actions. We must make absolutely sure that, if we are to countenance this, we do not make it an excuse for practices that we would all live to regret. 
Mr. Tom Clarke (Coatbridge and Chryston) (Lab) rose—

James Cran: I express my thanks to the right hon. Gentleman for taking over earlier and allowing me a modicum of relief.

Tom Clarke: I join my hon. Friend the Minister of State in welcoming you as Chairman of our Committee, Mr. Cran. Indeed, during those few moments when I proved to be a wholly inadequate substitute, I realised how onerous are the duties that we impose on you.

James Cran: Order. Insulting the Chairman is not allowed.

Tim Boswell: Or flattering the Chairman.

Tom Clarke: The ambiguities that have haunted the Committee thus far continue. From your viewpoint, Mr. Cran, I also realised what a fine body of men and women serve on this Committee.
 To turn to the serious aspects of our business, my purpose is to speak to my amendments Nos. 178, 179 and 180. I begin by declaring an interest as the co-Chairman of the all-party group on learning disabilities. I have had a great deal of help from that group as well as the Making Decisions Alliance, which, in truth, has been immensely helpful to all of us on the Committee. We appreciate very much the work that it does. 
 In the same way that people with impaired capacity should not be excluded from services and medical treatment, it is important not automatically to exclude them from research. I tabled the amendments because I believe that research raises several difficult ethical 
 questions; hence, the most stringent safeguards must be put in place. Dignity, privacy and protecting people from harm or exploitation must be paramount. I tabled the amendments to give my hon. Friend the Minister and the Committee the opportunity to reflect on and respond to the numerous representations that have been made to me and, doubtless, many other right hon. and hon. Members, not simply from the organisation that I mentioned but also from constituents in our surgeries, offices and elsewhere. 
 My hon. Friend the Minister said that ''reasonable grounds'' were a high test for someone to pass. Amendment No. 178 would make it absolutely clear in the Bill that it is simply not appropriate to carry out research on people who lack capacity if it is not possible to carry out the same research on people who can give their consent. That is a crucial issue for our discussion. My hon. Friend the Minister will recognise that that test is used in the Adults with Incapacity (Scotland) Act 2000, which has been highly praised on both sides of the Committee again this afternoon, and to which I have referred previously. I should be grateful for further expansion on the reasoning behind departing from that wording. I accept an argument that I myself made earlier: there is no reason, given our commitment to devolution as a United Kingdom Parliament, why we should expect devolved Assemblies to emulate everything that we are doing. It is fair to make that point. 
 Amendment No. 179 is essentially a probing amendment. I simply want to tease out and put on the record what my hon. Friend the Minister means by ''benefit''. The final amendment in the group, amendment No. 180, is also a probing amendment. It is worth highlighting that, as the clause stands, there are two potential get-outs for researchers. I seek reassurance from the Minister on a point that worries a great number of people, and certainly worries me. Researchers can undertake non-therapeutic research on an incapacitated person if they have 
''reasonable grounds for believing . . . that the risk to P from taking part in the project is likely to be negligible''.
 The word ''reasonable'' in such close proximity to ''likely'', and the looseness of phrasing, make me feel a little uncomfortable. I look forward to the Minister's explanation. Amendment No. 180 probes the Government's reason for wording the clause in that way.

Angela Browning: Is it not the case that, up and down the land, lawyers are making their fortunes, and always have done, on the interpretation of ''reasonable''? It seems to occur in court cases all the time. It is put into legislation so that, at the end of the day, everything is resolved by case law.

Tom Clarke: I am sure that the hon. Lady is making an important point. Tempting though it is to respond to the comment about lawyers, I simply say to the hon. Lady that, if she reads the Hansard in which the right hon. Member for Richmond, Yorks (Mr. Hague) introduced the Disability Discrimination Act to which the hon. Member for Daventry referred, she will see that that was a point of concern even then. I spoke for the Opposition on such matters then, and I fear that we have not removed the concern in the nine years that
 have since passed, and I doubt whether we will do so today.
 I should be most grateful if the Minister outlined what additional risk P would be exposed to by the use of words such as ''likely to be negligible'', rather than the use of the word ''no''. I hope that she can satisfy those concerns, and I look forward to her reply.

Paul Burstow: I want to address one of the most difficult issues in the Bill. I suspect that it has been grappled with, at least in part, in some detail and length during consideration of the Human Tissue Bill, when ethical issues about research and when it is appropriate, and the whole question of consent, were considered. I have also been wrestling with the question of quite how to deal with the problem.
 I was comforted by the evidence that the British Medical Association submitted to the Joint Committee during its scrutiny of the draft Bill. We were given a presentation from Dr. Nathanson from the BMA, who said that 
''a small amount of research does get carried out with very careful review by research ethics committees.''
 He was talking about research that was already taking place, albeit outwith a clear legal framework and without real safeguards other than those provided by medical ethics committees. One of the things that we were told on a number of occasions when considering the draft Bill was how the work undertaken by medical ethics committees has evolved over the last 20 years and become a better, more reliable and more robust way of providing safeguards when research is conducted. 
 It is important to keep in mind the fact that research is already being conducted. We should also bear in mind what happens as a consequence of some of that work. I am sure that other hon. Members have received numerous briefings on the matter. Reference has been made to a briefing that was sent to us from Birmingham. The medical research council of the Wellcome Trust has also provided a good briefing, giving a host of examples of research from which people could cease to gain direct and wider benefit if we took a strict view and said that in no circumstances could research take place if a person lacked capacity. 
 I shall refer to two examples, the first of which is of a condition called phenylketonuria—I am sure that I have not pronounced that right, so I hope that Hansard will help me out. The Wellcome Trust's briefing says: 
''Untreated phenylketonuria (PKU) used to result in profound learning disability. The clinical outcome of this condition has been dramatically altered by studies of adults and children with severe learning disability. These have led to the identification of a biochemical disorder in patients suffering with this condition that is treatable via removal of the amino acid phenylalanine from the diet. The biochemical disorder can be detected in newborn babies by the 'Guthrie test' ''.
 The briefing goes on to expand on that. The other example is from the CRASH trial, which looked at people with impaired consciousness and disability: 
''This trial examined the potential value of steroids in treating head injury and preventing prolonged disability. The original trial did not directly benefit those participating in it but has led to subsequent studies that have improved the treatment and likely outcome of patients suffering from such injuries.''
 Those two examples—there are others—are of studies that would probably not have taken place if we took the view, which some have understandably taken, that there should be no research where a person lacks capacity. As a consequence of that, many people would not benefit. 
 I understand that that could be seen as a utilitarian argument for allowing research to take place, but it cannot be entirely ignored. That is why I want to develop the point a bit further and get clarification on the wording of the Bill. It is important that some of the amendments seek to clarify precisely what the words are meant to mean. The right hon. Member for Coatbridge and Chryston (Mr. Clarke) raised the juxtaposition of the test of reasonableness, which is a good point. 
 Can the Minister say more about risk, which is dealt with in clause 31(5)(a)? The degree of risk that we are talking about needs to be clear, because clause 31(5)(a) says that it should be ''negligible''. What does that mean? The explanatory notes are no help whatever in further clarifying that, so I hope that the Minister can say a bit more about it. 
 Subsection (5)(b)(i) talks about not interfering 
''with P's freedom of action or privacy in a significant way'',
 but the explanatory notes do not explain what is meant by ''a significant way''. It would be helpful if the Minister gave us a feeling for what it might mean, so that those who will be required to operate under the provisions if the Bill becomes an Act can do so in a satisfactory way. 
 I was particularly struck by amendment No. 178, which would replace clause 31(3). It was tabled by the right hon. Member for Coatbridge and Chryston (Mr. Clarke), who is right to want to include in the Bill the proposition that it would be wrong for a person who lacked capacity to be the subject of research if a person who had capacity could be the subject of that research, and it would benefit from using such a person. It is important for the Bill to make that clear. 
 Clause 34 contains the power to stipulate who the appropriate authority or body will be, but it would be helpful if the Minister said a bit more about how that power will be used, because, again, the explanatory notes are far from clear. They state: 
''The Secretary of State must specify an appropriate authority for approving research projects'',
 and that is likely to be the research ethics committee. However, the explanatory notes do not say what conditions, regulations and requirements might be placed on the appropriate authority. It would be useful to know whether regulations could be laid saying not only that the committee will deal with the work, but how it will conduct that work. Is there scope for that? The way in which the Bill is drafted could be construed as meaning that there is not, but it would be helpful to have that made clear. 
 I want to conclude my contribution by reading again from the Joint Committee report, which makes some useful and insightful observations on this issue. Speaking of people who lack capacity, it says: 
''they should only be involved with medical research, if it is either in their best interests or if it is the only method of conducting research into their particular condition and everyone involved with the person is satisfied that this is a non-exploitative proposal which will not harm or distress the individual involved.''
 For those of us who think that research should take place, that must be the touchstone on which everything is based. If we go beyond that, we will get into waters that I would not want us to be in and begin to act in an unethical and unacceptable way.

Tim Boswell: The formulation that the hon. Gentleman has given us includes the important disjunctive ''or''. Does he think that the second test that he read out on behalf of the Joint Committee is different from the test of best interests? The difficulty is whether we will be at risk of breaching the principle if we have that in the Bill.

Paul Burstow: I am grateful to the hon. Gentleman because that allows me to move to my final point. The I Decide coalition has drawn hon. Members' attention to the judgment last year in respect of JS v. An NHS Trust and JA v. An NHS Trust. I want to quote from the judgment because it raises an interesting issue about real and direct benefit:
''It was in the best interests of the patients that the treatment be carried out. Although there was only a slight chance that the treatment would result in an improvement in the teenagers' condition, and there was no chance that the treatment could lead to recovery, both teenagers had lives worth preserving and any treatment that might be beneficial would be of value to them. A reduced enjoyment of life even at quite a low level was to be respected and protected, and even the prospect of a slightly longer life was a benefit worth having for these patients.''
 I guess that the dilemma is whether research that will have not even the slightest chance of providing a benefit for the individual should be authorised. Some of the research that I referred to earlier clearly could be in that category.

Ann Winterton: The hon. Gentleman quoted research being undertaken now without any regulation. Can he say whether it is being undertaken with the consent of relatives of the patient, if the patient cannot give theirs because of a lack of capacity?

Paul Burstow: That is a fair question, and I must admit that the briefing material on which I was relying does not answer it. However, it refers to the point that I was making earlier, which is that such research is happening now. If it is to happen—and, on balance, I am coming down on the side of the argument that there are circumstances in which research should take place—it should happen in a framework that provides substantial safeguards. The amendment of the hon. Member for Daventry, which would make it clear, for example, that advance directives have a part to play, is helpful. It is only right that people should be able to stipulate in advance that they are prepared to be a party to research.
 It has been put to me that those of us who have the capacity to participate in research do so only when we believe that we will get a direct benefit from it. I think that it is a false proposition based on little evidence. It is a pity that some people hold that view. It should not 
 be prayed in aid to suggest that those who lack capacity, but have others who can give consent in the circumstances set out in the Bill, should be able to take part in narrowly defined areas of research when there is no other way in which we can learn how to ensure that those people do not suffer in the future. That must be at the heart of our thinking. 
 I have tried to voice some of my concerns and ask the Minister to clarify a few of the key words in the Bill, so that we can have some more clarity. The clauses try to put in place safeguards. Those safeguards do not exist now, but research is taking place. The clauses are a way of ensuring that there are safeguards in future. For that reason, I broadly support them, although some of the amendments would help to clarify further and to improve the situation.

Ann Winterton: May I take the opportunity to thank my right hon. Friend the Member for Coatbridge and Chryston, as, through him, I welcomed you to the Chair, Mr. Cran? It is a bit of a long-winded way to go about it, but it was nevertheless a warm welcome. May I also say how much I look forward to serving under you?

James Cran: I am not quite sure whether I understand that.

Ann Winterton: Perhaps my right hon. Friend will explain it all later—it happened during your absence, Mr. Cran.
 We have had an interesting debate on the clauses on research, and I understand the concerns that people have—it is an emotive subject. Before I address the specific amendments, it would be helpful if I outlined some of the broader thinking behind why we have included these clauses and if I explained how we hope to achieve research that can lead to new and effective treatment, using procedures that balance that desire with effective safeguards for the individuals taking part. 
 It may also be helpful if I gave a clearer picture of the research that is covered and why we have included research that provides knowledge of the causes or treatment of a condition as well as research with the potential to benefit the person with the condition. I hope that that will help to allay some of the concerns about how research provisions fit in with the concept of best interests. It would be helpful, too, if I outlined some of the safeguards on participation in research and how the research provisions in the Bill relate to clinical trials. 
 Research is understandably a complex area to cover in the Bill, and some stakeholders expressed concern about our allowing medical and other research to take place at all when it involves people who lack the capacity to consent. We also discussed that matter on Second Reading. We appreciate that these are sensitive issues but, as we said to the Joint Committee, if we do not permit research into incapacitating conditions, treatment or prevention for those who could develop the conditions may be inhibited. Our key consideration is how to balance the need for such research with satisfactory safeguards. As the hon. Members for Tiverton and Honiton and for Sutton 
 and Cheam said, the Joint Committee heard a variety of representations on the issue, but concluded that the Bill should include provisions on research. It said that these should 
''enable strictly controlled medical research to explore the causes and consequences of mental incapacity and to develop effective treatment for such conditions. This . . . must include rigorous protocols to protect incapacitated adults from being exploited or harmed.''.

Angela Browning: Will the Minister reflect on sterilisation? Is she content for sterilisation per se to be included in research on incapacitated adults, or does she think that in that area of research it should be subject to an individual approval by the Court of Protection?

Ann Winterton: That decision would be taken by a research ethics committee. It would not be for Parliament to dictate what should or should not be in particular areas of research. I am not sure how the hon. Lady imagines the research taking place. The Bill contains clear safeguards about risk, and about not being unduly invasive. I am not sure how she wants us to proceed in respect of the parameters of different research, which would depend on the conditions set by a medical ethics committee, and on the safeguards in the Bill.

Paul Burstow: Surely sterilisation is a treatment; in the context of our discussion about research, it is not something that one would carry out for research purposes. I would be most concerned if it were considered that it could be dealt with in the context of these provisions. I should have thought that it was outwith them, and I hope that the Minister can reassure us on that matter.

Ann Winterton: That is why I was explaining that I did not understand how the hon. Lady was imagining that research—I do not know whether she meant research into sterilisation, and how that would take place—unless it was something that would not necessarily benefit the person, and was also invasive—

Angela Browning: Perhaps I should have coupled sterilisation with fertility.

Ann Winterton: Again, I would say that some of these procedures would be treatments, as opposed to research. I am not quite sure whether the hon. Lady was saying that if an individual had been given fertility treatment or had been sterilised, research would then be carried out into the effects of that. That would be a matter for a research ethics committee, within the parameters and safeguards in the Bill, about the extent to which risk should be considered.
 The Committee suggested a number of key principles that should govern participation in research. It said that projects should be reviewed by properly established independent ethics committees. We have said that an appropriate body such as an ethics committee must approve all projects. 
 The hon. Member for Sutton and Cheam asked what other bodies might be appropriate, and whether regulations should set out the way in which they do their work. In some of the social care aspects of research, social care bodies, as opposed to research 
 ethics committees, will that carry that out. Also, in any code of practice or regulations there would be a clear steer towards sticking to the principles in the Bill with regard to obtaining consent for somebody to participate in the research. We would expect the research ethics committees to adhere to that. 
 We have made it clear that all research projects must satisfy the strict conditions that we have set out in clause 31 in order to gain such approval. The research ethics committee would examine the requirements in clause 31 before it could give approval. The criteria that such committees would be expected to stick to are in the Bill.

Paul Burstow: For the sake of clarity, will the Minister confirm whether the power under clause 30(4) will allow the Government of the day, as part of nominating an ''appropriate body'', to stipulate—if they wanted to and felt that it was appropriate—its form, make-up, members and so on? Does it allow the Government to stipulate beyond what the appropriate body will be—for example, the way in which it will conduct its work?

Ann Winterton: Yes, it would. The reason why that phrasing is included is that an appropriate body is not necessarily a research ethics committee. As I have said, in some social care research projects it can be a different type of body. The Committee also said that care should be taken to ensure that consent was freely given. That is why we specified in clause 32 that carers must be consulted, or, where no carer exists, that an independent person who can be consulted on the person's participation must be found. The Committee said that discomfort must be minimal, and the researchers should respect any indication of dissent.
 Clause 31 is clear that for research that may benefit a person, any burdens must not be 
''disproportionate to the potential benefit'',
 and that for research to develop new knowledge of the condition, the risks must be ''likely to be negligible''. I understand the point that was made by my right hon. Friend the Member for Coatbridge and Chryston , and I will be talk about that later when dealing with the amendments. 
 Under clause 33, nothing may be done to a person if he objects, and if at any time he indicates 
that he wishes to be withdrawn . . . he must be withdrawn without delay.''
 For example, a person might resist when asked to perform a particular task or to be subject to certain procedure, such as blood pressure measurement. He may refuse to co-operate about going into a research clinic. All such wishes must be respected by the researcher at the time. However, the researcher may want to approach P on another occasion or in a different way, in which case P might be more willing to participate. 
 Alternatively, P may confide in a carer that he does not like the research or that the prospect of it is upsetting to him. The carer can pass that on to the researcher or, if the carer is the person to be consulted, he has the right to say at any time that he wants to withdraw P from the study, and the researcher must 
 comply with that wish. We consider that the Bill provides a good balance between protecting the individual today and potentially benefiting that individual, or others with similar conditions, tomorrow. 
 The hon. Member for Daventry referred to the relationship with the Human Tissue Bill and organ donations. If a mentally incapacitated person died, the hon. Gentleman asked whether that person's body could be used for research. Such matters are covered under the Human Tissue Bill. The same provision relates to anyone else. If an incapacitated person dies without having made a prior decision, his body may be used for research with the consent of a nominated representative, if appointed by the person while he had capacity or a person who was in a qualifying relationship as set out under the Human Tissue Bill.

Tim Boswell: My concern was not only to make sure that there was a suitable and dignified regime for persons who lacked capacity after they had lost their lives, but to make sure that the safeguards for those persons while in vivo, when research might be conducted on them, are at least as strong as those that would apply to their cadaver after their death.

Ann Winterton: That would be the case. As for organ donation, the situation would be the same. If the person carried an organ donor card, his relatives would be informed that that had been his wish. If he did not, the relatives would be asked whether they were happy for his organs to be used for donation. The same would apply to an incapacitated person as to any other person.
 We have had extensive discussions about best interests. It could be said that it was difficult to align a narrow interpretation of best interests with some key aspects of research. Some research might benefit a person, but it may not have been established that the treatment under investigation is necessarily better than the standard care already being given. A doctor may decide that P is suitable to be included in a research trial of a promising and safe new surgical procedure. The doctor is expected to make that assessment and treatment decision in P's best interests. However, it may not necessarily be in P's best interests to be subjected to additional X-rays or blood measurements, to be followed up with the extra measurements that are an essential part of the research project. 
 So there needs to be independent oversight of research by an ethics committee. It should consider whether the research is lawful and whether it will potentially benefit an individual or yield important scientific knowledge. Crucially, the patient should not be harmed or his privacy or rights infringed. If the research has those safeguards, it can be said to be consistent with P's best interests, as it will potentially benefit P or those in a similar position. 
 We have agreed with the view put to us by many organisations that to deny adults without capacity the opportunity to be involved in well run research would mean that their special requirements and experiences were not considered in developing treatment and care 
 programmes or evaluating best practice. Ultimately, sometimes there may not be an immediate benefit, but there may be a benefit at a later stage if new treatments or care plans are established as a result of good research evidence. 
 With amendment No. 41, the hon. Member for Daventry is seeking to ensure that the previously expressed wishes of people who lack capacity are respected when their involvement in approved research projects is considered. The principle is right, but unfortunately the amendment would prevent most people from participating in, and potentially benefiting from, properly conducted clinical and social care research. 
 We must recognise that many people will not have considered their possible involvement in research before they lost the capacity to consent. Some important groups of adults without capacity may never have had an opportunity to make formal advance decisions before they lost capacity. I am thinking of adults with lifelong learning disability, and those who suffer sudden and unexpected loss of capacity due to a head injury, stroke or infection. Under the amendment, if there were no advance decision authorising research, research would be deemed unlawful. That would mean long delays in enrolling people in research programmes and, consequently, in the development of new treatments. 
 That said, the Bill recognises the importance of ensuring that research takes proper account of a person's previously stated wishes and feelings. Clause 33(2)(b) says that nothing may be done to P in the course of research 
''which would be contrary to an advance decision''.
 The clause also requires that any sign of objection by P, or any indication that he wishes to withdraw from research, be respected. 
 Amendments Nos. 42 and 43 would remove the references to ''clinical trials regulations''. The hon. Gentleman thereby proposes to bring clinical trials of medicines within the scope of the Bill. Perhaps it would make things clearer if I were to compare the main aspects of the regulations with the Bill. The Medicines for Human Use (Clinical Trials) Regulations 2004 cover all clinical research involving investigational medicinal products—trials that will involve giving people active substances such as drugs or vaccines. The Bill covers a much broader area of potential research, such as research on tissue samples taken for clinical purposes, examining medical records or asking patients' views on treatments or care that they have received. 
 I shall give examples of the sort of research that that means. The clinical trials regulations cover IMAGES—the intravenous magnesium efficacy in acute stroke clinical trial—in which magnesium treatment was shown to be effective in the treatment of strokes. To design that trial, the researchers had carried out observational research on stroke patients, many of whom were unable to consent for themselves. The research included measuring their blood pressure and collecting blood samples repeatedly over a few 
 days to assess levels of hormones and body salts, including magnesium. The results of the research led to improvements in treatment for stroke patients. 
 The Bill would cover projects such as research that my Department funds as part of the programme of research on learning disabilities, including studies with adults with learning disabilities on the benefits of health facilitators, spotting symptoms of sexual abuse and assessing the effect of cognitive behaviour therapy. That research is only ever likely to have an indirect impact—if it has any impact at all—by influencing future policy and practice. It might, however, be of direct personal benefit to P at some point in the future, if the services that he or she receives were to be improved as a result of the research. 
 The clinical trials regulations cover all patients, including those with mental incapacity, and minors, whereas the Bill deals only with people who lack capacity. In both cases there must be approval for research by the Medicines and Healthcare products Regulatory Agency, and by a research ethics committee for clinical trials and an ''appropriate body'' for the Bill, which would probably also be a research ethics committee. 
 The clinical trials regulations require informed consent given by a legal representative whereas the Bill requires a researcher to consult with someone engaged in caring for, or interested in the welfare of, P. If at any time that person says that P would not have wanted to take part in the research, P must not take part. 
 The Bill covers a much broader area of research; it therefore seemed right to use different safeguards to cover that broader area. The Bill has been carefully drafted to reflect and respect the extensive work done to develop a harmonised system for clinical trials of new medicines. 
 The 2001 EC directive sets out internationally accepted standards of good clinical practice and manufacturing practice and also covers independent oversight of clinical trials by ethics committees. It was implemented in full in the UK by 1 May and makes extensive provision for research involving those who lack capacity. Those measures have been agreed internationally as appropriate for research and are aimed at protecting vulnerable groups of people in research that involves giving them active substances such as drugs or vaccines. 
 However, the Bill's provisions are much wider. They include social care research, such as interviewing service users about their care, or carefully controlled access to data from patient records, with, as I said, all the safeguards that have been built in at the same time. We are very confident that we have two complementary regulatory systems that are equally effective in ensuring the appropriate regulation of research involving adults with incapacity. 
 Amendments Nos. 178 and 179 would place tighter restrictions on participation in research. Clause 31(3) requires the researcher to have 
''reasonable grounds for believing that the research would not be as effective if carried out only on, or only in relation to, persons who have capacity to consent to taking part in the project.''
 My right hon. Friend the Member for Coatbridge and Chryston seeks to simplify and clarify the intention of subsection (3). The problem, however, is that the amendment risks making it very much more difficult for a research ethics committee to decide whether the research can be approved. 
 Subsection (3) is intended to ensure that research is not conducted on a person who lacks capacity if such research could be done equally well on people with capacity. This is sometimes called the no alternative criterion. As I said, the subsection is one of several safeguards that we built into the Bill. It is also important that we recognise that the design and conduct of research become increasingly complex as our understanding of medicine and biology increases. I am concerned that it would become inordinately difficult for a research ethics committee to decide whether another similar line of research exists that might involve adults with capacity. 
 As I already explained, a researcher must comply with a very strict set of statutory provisions to secure approval for a project. It is right that we allow a research ethics committee to apply its judgment so that each application can be considered on its merits. I understand my right hon. Friend's concerns, but his amendment would restrict research. 
 Amendment No. 179 would also tighten the criteria for accepting research projects. Again, I am very sympathetic to the sentiment behind the amendment, which obviously aims to leave no room for doubt that research involving an incapacitated person could be carried out only if there was real certainty that it would benefit the person. I re-emphasise that the clause is clear on this point. It states that the research must have the potential to benefit P. Adding the words ''real and direct'' would not improve its clarity. As we have said, this would complicate an already quite difficult judgment. 
 The Joint Committee agreed that, even if research is therapeutic, it would be difficult for a research ethics committee to be able to say for certain that research can be of real and direct benefit to the person. It would be even more difficult to demonstrate that in other settings, such as social care. 
 I entirely understand why people are concerned to ensure that research that involves someone who lacks capacity to consent can be approved only if there is real benefit to the person, but again, the evidence to the Joint Committee was quite clear: it can never be guaranteed to benefit an individual. As was said earlier, if the research was guaranteed to benefit a person, what was involved would be given in the first place; there would be no need for the research. 
 Amendment No. 44 again concerns removing provisions for non-therapeutic research from the Bill. The problem is that the amendment would remove provision for an important area of research. For some research, it may be hard to show that there is direct benefit. For example, in surgery to treat patients with a brain haemorrhage it is vital that patients have sufficient anaesthetic to relieve pain, but not so much 
 that it might further damage their brain. Research to choose the best pain-monitoring device will benefit future patients, but there can be no certain direct benefit to any particular patient from that study. 
 Amendment No. 180 would place similar limits on research, stating that there should be ''no risk'' to research carried out. However, just as it is difficult to establish direct benefit, it can be almost impossible to guarantee that there is no risk to any activity. I completely understand the sentiment behind my right hon. Friend's amendment, but it is untenable because it is simply not possible to guarantee that there will be no risk to a person, in that or any other situation. 
 I hope that, with the reassurances and clarification that I have given, the hon. Member for Daventry feels able to withdraw his amendment.

Tim Boswell: I thank the Minister for giving an extended response. She has sought to give explanations and assurances that are helpful to the Committee. We will need to go away, look at the record carefully and reflect on the issue.
 My personal reservations have not been entirely allayed. My first reservation involves safeguards. Nobody wants a bureaucratic or complex system that cannot respond to a particular situation. It is equally important, given the sensitivity of the subject, 
 which has been accepted on both sides of the Committee, to ensure that safeguards are sufficient. 
 My second reservation involves the principle. I note that the Minister did not specifically respond on whether the best interest test covers this clause, save only by extending the context to the widest possible interpretation of best interest, which is the response I anticipated. I want to reflect on that. In effect, she was saying that if it might do some good either to P or to somebody else with P's condition, this is in P's best interests or is certainly not inimical to them. 
 I understand that approach. It would be objectionable in principle to exclude best interests from the clause, so we must consider whether this is a legitimate way to deal with the problem. I suspect that it will inevitably end up being tested in court, or possibly in the European Court. 
 Rather than exercising our right to vote on the matter, we will go away, reflect and consider whether we wish to return to it. I beg to ask leave to withdraw the amendment. 
 Amendment, by leave, withdrawn. 
 Clause 30 ordered to stand part of the Bill. 
 Further consideration adjourned.—[Ms Bridget Prentice.] 
 Adjourned accordingly at fifteen minutes past Five o'clock till Tuesday 2 November at half-past Nine o'clock.